Polaris - Crestor 40 mg vs Atorvastatin 80 mg for 26 Weeks

Phase 3

Completed

• Conditions: Hypercholesterolemia; Coronary Heart Disease
• Interventions: Drug: Rosuvastatin; Drug: Atorvastatin

• Registration Number: NCT00653588
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study Completion: 2004-09
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
• Fasting LDL-C concentrations at Visit 1 as defined in the protocol.

Exclusion Criteria

• History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
• Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
• Severe congestive cardiac failure (as defined by the protocol - Appendix I).
• Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	rosuvastatin (40 mg)
2	Atorvastatin	atorvastatin (80 mg)

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of rosuvastatin with atorvastatin by assessing the percentage change from baseline to week 8 in LDL-C concentrations in subjects with hypercholesterolaemia and CHD or CHD risk equivalents.

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8